Phenx Toolkit Supplemental Information s2

PhenX Toolkit Supplemental Information Domain: Ocular Release Date: February 26, 2010 Visual Field: Field Protocol

About the Measure

Domain Ocular

Measure Visual Field: Field Protocol

Definition Measurement of an individual's vision field (central and peripheral vision) will be tested with Frequency Doubling Technology (FDT) using the Humphrey Matrix perimetry instrument.

About the Protocol

Description of Visual field testing is performed on each eye of the participant using Protocol the Full-Threshold N-30 (N-30-F) and the 24-2 Threshold procedures on the Humphrey Matrix Frequency Doubling Technology (FDT) visual field instrument (Carl Zeiss Meditec, Inc., Dublin, CA).

Protocol text Subjects will have two Frequency Doubling Technology (FDT) tests using the Humphrey Matrix, the Full-Threshold N-30 (N-30-F) and the 24-2 Threshold procedures performed on each eye. To perform both the N-30-F and 24-2 tests, it is essential that you have a Humphrey Matrix and not an original FDT instrument.

The tests should be administered using the Subject’s normal distance correction (glasses or contact lenses). Eyeglasses with bifocal corrections can be used.

ENTERING SUBJECT DATA 0 1. The MAIN MENU can be accessed by pressing the F1 button located at the upper right corner of the Humphrey Matrix Screen.

2. From the MAIN MENU of the HUMPHREY MATRIX, select N-30-F FDT Threshold or 24-2 FDT Threshold under the Threshold menu by pressing this location on the screen.

3. After this selection, you will be taken to the “View Patients” screen. Select “Add New Patient” by pressing this button at the top left portion of the screen and enter in the subject ID and date of birth, other information. After this select “Add Patient” by pressing the button in the lower right portion of the screen.

PhenX Toolkit Supplemental Information Visual Field: Field Protocol PhenX Toolkit Supplemental Information Domain: Ocular Release Date: February 26, 2010 Visual Field: Field Protocol

4. Enter the Pupil Diameter, Visual Acuity, and Rx as described in the table below.

FDT Screen: Information Entered: Pupil Diameter RE: e.g., 4 mm LE: Visual Acuity RE: e,g,, 20/20 LE: Rx Used RE: 1(+ or -) _.__ DS (+ or -) _.__DC X ___DEG LE: (+ or -) _.__ DS (+ or -) _.__DC X ___DEG 1Enter 3 digits for each, 0.00 for plano. “Rx Used” is the correction that is used for performing visual field testing.

5. The Operator LCD Display will indicate if there is too much ambient light to perform a reliable test. Lower the room lighting or change the test location until suitable test conditions are achieved. Also, if the subject response button is not connected or the subject visor is in the wrong eye position, this will be indicated on the operator LCD display.

PREPARING THE SUBJECT

For the eye being tested, if the brow is heavy or the upper lid is drooping, tape it accordingly. When in doubt, tape the upper lid. Slide the subject visor to the study eye test position and ask the Subject to place their forehead on the forehead rest and look into the subject eyepiece at the video screen. Adjust the height of the chair or table (or both) to obtain a comfortable position for the Subject. Confirm that the Subject can see the entire lit video screen, including all four corners in the subject eyepiece, establish that they can see the black dot in the middle of the screen and that their eye is centered on the video screen. Make sure that the Subject is properly aligned with the instrument by asking him/her to look to each of the four corners of the display to make sure that the display is not obscured.

Select the “Freeze” button to freeze the live image of the eye to measure the Subject’s pupil diameter. Measure the Subject’s pupils to the nearest 0.5 mm. If they are less than 3 mm in diameter, dilate them with 2.5% phenylephrine drops, unless contraindicated. If this is ineffective, dilate with a cycloplegic agent and wait a full 20 minutes before beginning the test. If a Subject’s pupil is < 3 mm with cycloplegia, he/she is ineligible for visual field testing and cannot be enrolled in the study. After measuring the Subject’s pupil diameter, press the “Unfreeze” button to return to a live video of the Subject’s eye. 1 FDT N-30-F and 24-2 SUBJECT INSTRUCTIONS

Read the Subject the following instructions: “A demonstration of the test is running now. Can you see the black square (dot) in the center and the entire lit video screen? You need to stare at the black dot in the center of the screen during the entire test.”

“From time to time, you will see patterns of flickering black and white vertical bars that will briefly appear in different areas of the screen. The pattern will sometimes be very faint and at other times be very distinct. You are not expected to see the bar patterns at all times. Each time you see something flickering, press the response button once. Can you see these patterns in the demonstration running now? You may practice now by pressing the button to respond to the patterns.”

“It is OK to blink, a good time to blink is when you press the response button. If you need to rest or ask questions during the test, you can pause the test at any time by pressing and holding down the response button. Do you have any questions? Do you understand how to take the test?”

“I will now start the test. There will be a few brief flashes and then the test will begin. Press the response button once each time you see something flickering. Please remember to stare at the black square (dot) in the center of the screen during the entire test.”

During the test, you will see the Subject’s pupil in the black box below. Keep an eye on the Subject’s pupil to make sure that they are maintaining fixation on the black dot in the center of the screen and that the pupil is inside the circle in the black box. Notes concerning the test can be added to the “Notes” box.

SAVING & PRINTING THE FDT RESULTS Save a CSV and PDF version of the Subject’s data. Print out the test results at the completion of each test.

Participant Adults ≥ 18 years

Source Visual Field Reading Center, Department of Ophthalmology & Visual Science, University of Iowa Hospitals & Clinics Standard Automated Perimetry (SAP), Humphrey Matrix & Frequency Doubling Technology (FTD) Visual Field Guidelines, Version date 9/9/09.

Language of English Source

Personnel and Trained ophthalmic technician or ophthalmologist Training Required

Equipment Needs Humphrey Matrix Frequency Doubling Technology (FDT) visual field instrument. (Carl Zeiss Meditec, Inc., Dublin, CA)

Note: This protocol for visual field uses the Humphrey Matrix Frequency Doubling Technology (FDT) visual field instrument. If other instruments are used, the reproducibility of the measurements should be comparable to those acquired with this protocol. In addition, when other instruments are used to collect these measurements, the manufacturer and model of equipment should be recorded. These other devices may require some different steps than are described in this protocol. Investigators should follow the equipment manufacturer’s instructions to ensure quality control.

Protocol Type Physical measurement

General References None

PhenX Toolkit Supplemental Information Visual Field: Field Protocol